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Sorrento Therapeutics (NASDAQ:SRNE) announced that the U.S. Food and Drug Administration (FDA) has cleared the Phase 1 study of its candidate, STI-1558, in patients with impaired renal and hepatic function.
STI-1558 is an oral SARS-CoV-2 main protease inhibitor which can block viral replication, is specifically designed as a standalone treatment of COVID-19.
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The Phase 1 study cleared by the FDA is designed to examine the pharmacokinetic (PK) in patients with moderate renal and hepatic impairment.
Two doses of STI-1558 (300 mg and 600 mg) will be studied in 12 subjects across 3 cohorts, 12 normal subjects, 12 renally-impaired subjects and 12 hepatically-impaired subjects, using a cross-over design.
The ongoing Phase 1 Study of STI-1558 evaluating single ascending doses (SAD), multiple ascending doses (MAD) and food effect is proceeding in Australia, and the drug has been dosed in patients in the first 3 cohorts with doses of 300, 600 and 1,200 mg.
Henry Ji, Chairman, President and CEO, commented : "STI-1558 has the potential to be a highly effective antiviral treatment for acute COVID-19 and we look forward to seeing how it performs in the Phase 1 study and the planned Phase 2/3 study.”
Price Action : Sorrento shares are trading around 8 percent higher at $2.67 on Tuesday at the time of publishing.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.